# K172497: NuVasive AttraX Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Nov 24, 2017 after 98 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050789: Formagraft Collagen Bone Graft Matrix, R and D Medical, LLC (2005) Summary page 4.
- K151584: AttraX Putty, Progentix Orthobiology BV (2015) Summary page 4.
- K090641: Curios, Progentix Orthobiology BV (2009) Summary page 4.

## Most influential descendants
- K240507: NuVasive AttraX Scaffold (2024), 0 descendants of its own

## Indications for use
AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. AttraX Scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K172497
Methodology: https://510kreport.com/methodology